Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

February 29, 2028

Study Completion Date

February 28, 2030

Conditions
Colorectal Cancer MetastaticIntrahepatic Cholangiocarcinoma
Interventions
DEVICE

Hepatic Artery Infusion Pump (HAIP)

HAIP will be filled with mixture of FUDR + Dexamethasone, Heparin \& Saline for a 14 day infusion of drugs, followed by a 14 day infusion of Heparin+Saline.

PROCEDURE

Standard Treatment

systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation

PROCEDURE

Community Treatment

systemic therapy fill by home infusion based on TO orders. In person visit with CO for systemic chemotherapy with dose recommendations from TO. Locally obtained testing with telehealth visits with TO team.

DRUG

Systemic Chemotherapy Standard of Care

"Dosing of systemic therapy will be according to established routine practice guidelines. Patients with colon cancer will receive systemic chemotherapy that will consist of either FOLFIRI, FOLFOX, or Irinotecan/oxaliplatin at the discretion of the oncologist.~Patients with intrahepatic cholangiocarcinoma will receive Gemcitabine/Oxaliplatin or Gemcitabine alone, at the discretion of the oncologist."

DRUG

Standard Of Care targeting driver mutations

Per current SOC guidelines, EGFR inhibitors targeting driver mutations (e.g., RAS wild-type) will be administered as appropriate (FDA-approved agents such as Panitumumab for EGFR)

Trial Locations (1)

40506

University of Kentucky, Lexington

All Listed Sponsors
lead

Michael J Cavnar, MD

OTHER